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NCT03923348 · ClinicalTrials.gov registry record · NA
Pelvic Floor Muscle Training With Leva System for Urge Incontinence
A NA study, sponsored by The Christ Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT03923348: Clinical Trial NA study, sponsored by The Christ Hospital.
NCT03923348 is a NA study that was terminated before completion, run by The Christ Hospital. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03923348, a NA study, was terminated before completion, sponsored by The Christ Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.
Primary Outcome
The Urogenital Distress Inventory (UDI) is a 19-item questionnaire assessing subjective symptoms of pelvic floor disorders including incontinence. The 19 items fall into one of three subscales (Irritative symptoms, Obstructive symptoms, and Stress Symptoms). . The subject responds to each item by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. For scoring, first each subscale score is calculated by finding the mean score of items
Interventions
- DEVICE Leva device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2020-05-04 |
| Phase | NA |
Why NCT03923348 stopped before completion
NCT03923348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Leva device is the first listed.
NCT03923348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03923348 about?
NCT03923348 is a clinical study titled "Pelvic Floor Muscle Training With Leva System for Urge Incontinence". This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 w...
What is the current status of trial NCT03923348?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2019-06-06. Estimated completion is 2020-05-04.
What interventions are being tested in trial NCT03923348?
The interventions under investigation include: Leva device (DEVICE).
Who is sponsoring clinical trial NCT03923348?
This trial is sponsored by The Christ Hospital, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03923348's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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